One-way valve devices for anchored implantation in a lung

ABSTRACT

An intra-bronchial device placed and anchored in an air passageway of a patient to collapse a lung portion associated with the air passageway. The device includes a support structure, an obstructing member carried by the support structure that reduces ventilation to the lung portion by preventing air from being inhaled into the lung portion, and at least one anchor carried by the support structure that anchors the obstruction device within the air passageway. The anchor may engage the air passageway wall by piercing or friction, include a stop dimensioned for limiting the piercing of the air passageway wall, and may be releasable from the air passageway for removal of the intra-bronchial device. The anchors may be carried by a peripheral portion of the support structure, or by a central portion of the support structure. The obstructing member may be a one-way valve.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/150,547,filed on May 17, 2002, the entire contents of which are incorporatedherein by reference.

BACKGROUND

The present invention is generally directed to a removable anchoreddevice, system, and method for treating Chronic Obstructive PulmonaryDisease (COPD). The present invention is more particularly directed toproviding an anchored intra-bronchial obstruction that may be removable.

COPD has become a major cause of morbidity and mortality in the UnitedStates over the last three decades. COPD is characterized by thepresence of airflow obstruction due to chronic bronchitis or emphysema.The airflow obstruction in COPD is due largely to structuralabnormalities in the smaller airways. Important causes are inflammation,fibrosis, goblet cell metaplasia, and smooth muscle hypertrophy interminal bronchioles.

The incidence, prevalence, and health-related costs of COPD are on therise. Mortality due to COPD is also on the rise. In 1991, COPD was thefourth leading cause of death in the United States and had increased 33%since 1979. COPD affects the patient's whole life. It has three mainsymptoms: cough; breathlessness; and wheeze. At first, breathlessnessmay be noticed when running for a bus, digging in the garden, or walkinguphill. Later, it may be noticed when simply walking in the kitchen.Over time, it may occur with less and less effort until it is presentall of the time. COPD is a progressive disease and currently has nocure. Current treatments for COPD include the prevention of furtherrespiratory damage, pharmacotherapy, and surgery. Each is discussedbelow.

The prevention of further respiratory damage entails the adoption of ahealthy lifestyle. Smoking cessation is believed to be the single mostimportant therapeutic intervention. However, regular exercise and weightcontrol are also important. Patients whose symptoms restrict their dailyactivities or who otherwise have an impaired quality of life may requirea pulmonary rehabilitation program including ventilatory muscle trainingand breathing retraining. Long-term oxygen therapy may also becomenecessary.

Pharmacotherapy may include bronchodilator therapy to open up theairways as much as possible or inhaled beta-agonists. For those patientswho respond poorly to the foregoing or who have persistent symptoms,ipratropium bromide may be indicated. Further, courses of steroids, suchas corticosteroids, may be required. Lastly, antibiotics may be requiredto prevent infections and influenza and pneumococcal vaccines may beroutinely administered. Unfortunately, there is no evidence that early,regular use of pharmacotherapy will alter the progression of COPD.

About 40 years ago, it was first postulated that the tethering forcethat tends to keep the intrathoracic airways open was lost in emphysemaand that by surgically removing the most affected parts of the lungs,the force could be partially restored. Although the surgery was deemedpromising, the lung volume reduction surgery (LVRS) procedure wasabandoned. LVRS was later revived. In the early 1990's, hundreds ofpatients underwent the procedure. However, the procedure fell out offavor when Medicare stopped reimbursing for LVRS. Unfortunately, data isrelatively scarce and many factors conspire to make what data existsdifficult to interpret. The procedure is currently under review in acontrolled clinical trial. However, what data does exist tends toindicate that patients benefited from the procedure in terms of anincrease in forced expiratory volume, a decrease in total lung capacity,and a significant improvement in lung function, dyspnea, and quality oflife. Improvements in pulmonary function after LVRS have been attributedto at least four possible mechanisms. These include enhanced elasticrecoil, correction of ventilation/perfusion mismatch, improvedefficiency of respiratory musculature, and improved right ventricularfilling.

Lastly, lung transplantation is also an option. Today, COPD is the mostcommon diagnosis for which lung transplantation is considered.Unfortunately, this consideration is given for only those with advancedCOPD. Given the limited availability of donor organs, lung transplant isfar from being available to all patients.

There is a need for additional non-surgical options for permanentlytreating COPD. A promising new therapy includes non-surgical apparatusand procedures for lung volume reduction by permanently obstructing theair passageway that communicates with the portion of the lung to becollapsed. The therapy includes placing an obstruction in the airpassageway that prevents inhaled air from flowing into the portion ofthe lung to be collapsed. Lung volume reduction with concomitantimproved pulmonary function may be obtained without the need forsurgery. The effectiveness of obstructions may be enhanced if it isanchored in place. The effectiveness may also be enhanced if theobstruction is removable. However, no readily available apparatus andmethod exists for anchoring the obstruction, and for removal ifrequired.

In view of the foregoing, there is a need in the art for a new andimproved apparatus and method for permanently obstructing an airpassageway that is anchored in place, and that may be removed ifrequired. The present invention is directed to a device, system, andmethod that provide such an improved apparatus and method for treatingCOPD.

SUMMARY

The present invention provides an anchored intra-bronchial device forplacement in an air passageway of a patient to collapse a lung portionassociated with the air passageway. The device includes a supportstructure, an obstructing member carried by the support structure thatprevents air from being inhaled into the lung portion to collapse thelung portion, and at least one anchor carried by the support structurethat anchors the obstruction device within the air passageway when theanchor is deployed. The support structure, or a portion thereof, may becollapsible. The obstructing member and at least one anchor may besimultaneously deployable. The support structure may be configured tourge at least one anchor to engage the air passageway wall. Theobstructing member may be a one-way valve. The obstructing member may bereleasable from the support structure and removable from the airpassageway.

In accordance with the present invention, alternative embodiments areprovided for the anchors. An anchor may have an anchoring end thatengages the air passageway wall, and that may pierce into the airpassageway wall. An anchor may include a stop dimensioned for limitingthe piercing of the air passageway wall. An anchor may include aresilient material for imparting a force against the air passageway todeform the air passageway to more positively anchor the obstructingmember. An anchor may be releasable from the air passageway for removalof the intra-bronchial device. An anchor may include a pad thatfrictionally engages the air passageway. Further, an anchor may beconfigured to move from a first configuration to a second configurationto engage the air passageway. An anchor may be configured to move from afirst configuration to a second configuration to engage the airpassageway, and to move from the second configuration to the firstconfiguration to disengage the air passageway. Alternatively, an anchormay be configured to move from a first configuration to a secondconfiguration to engage the air passageway, and to move from the secondconfiguration to a third configuration to disengage the air passageway.

In accordance with the present invention, alternative embodimentsprovide for the anchors to be carried on different portions of thedevice. An anchor may be carried by a peripheral portion of the supportstructure, and/or by a central portion of the support structure. Ananchor may be carried distal to the obstructing member, and/or proximalto the obstructing member.

The present invention further provides a method of reducing the size ofa lung, or reducing ventilation to a portion of a lung, by collapsing atleast a portion of the lung. The method includes the step of providingan intra-bronchial device that includes a support structure, anobstructing member carried by the support structure which is sodimensioned when deployed in an air passageway communicating with theportion of the lung to be collapsed to preclude air from being inhaled,and at least one anchor carried by the support structure that anchorsthe obstructing member when the anchor is deployed. The method furtherincludes the steps of placing the obstructing member in the airpassageway, and deploying at least one anchor. An anchor may bereleasable for removal of the intra-bronchial device. The obstructingmember may form a one-way valve. The support structure may becollapsible.

The present invention yet further provides a method of reducing the sizeof a lung, or reducing ventilation to a portion of a lung, by collapsinga portion of the lung with a removable device. The method includes thestep of providing an intra-bronchial device comprising a supportstructure, an obstructing member carried by the support structure whichis so dimensioned when deployed in an air passageway communicating withthe portion of the lung to be collapsed to preclude air from beinginhaled, and at least one anchor carried by the support structure thatanchors the obstructing member when the anchor is deployed. The methodfurther includes the steps of placing the obstructing member in the airpassageway, and deploying at least one anchor. The method furtherincludes the step of removing at least the obstructing member. At leastone anchor may be releasable from the air passageway for removal of atleast the obstructing device, and the step of removing at least theobstructing device includes releasing at least one anchor. At least aportion of the obstructing member is releasable from the supportstructure, and the step of removing at least the obstructing memberincludes releasing the obstructing member from the support structure.The obstructing member may form a one-way valve. At least a portion ofthe support structure may be collapsible.

The present invention additionally provides an air passagewayobstructing device. The device includes frame means for forming asupport structure, flexible membrane means for obstructing air flowwithin the air passageway and carried by the support structure, andanchoring means to anchor the air passageway obstructing device, carriedby the support structure. The frame means is expandable to an expandedstate within an air passageway to support the membrane means and theanchoring means. The anchoring means is releasable for removal of thedevice from the air passageway.

These and various other features as well as advantages whichcharacterize the present invention will be apparent from a reading ofthe following detailed description and a review of the associateddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like referenced numerals identify like elements, and wherein:

FIG. 1 is a simplified sectional view of a thorax illustrating a healthyrespiratory system;

FIG. 2 is a sectional view similar to FIG. 1, but illustrating arespiratory system suffering from COPD and the execution of a first stepin treating the COPD condition by reducing the size of a lung portion inaccordance with the present invention;

FIG. 3 is perspective view, partially in section, and to an enlargedscale, illustrating an intermediate step in the treatment;

FIG. 4 is a perspective view of a conduit that may be utilized inpracticing the present invention;

FIG. 5 is a perspective view of an intra-bronchial device, with anchorslocated proximally on peripheral portions of the support members, as thedevice would appear when fully deployed in an air passageway inaccordance with the present invention;

FIG. 6 is a partial section view of the device of FIG. 5 showingadditional details of the support structure;

FIG. 7 is a perspective view of the intra-bronchial device of FIG. 5anchored in an air passageway;

FIG. 8 illustrates an intra-bronchial device, with anchors carrieddistally on the central support structure, fully deployed in an airpassageway in accordance with an alternative embodiment of theinvention;

FIG. 9 is a perspective view of an intra-bronchial device, with proximalanchors carried on the central support structure, in accordance with analternative embodiment of the invention;

FIG. 10 is a side view of an intra-bronchial device, with proximalanchors carried on the central support structure, in accordance with analternative embodiment of the invention;

FIG. 11 is an end view of an intra-bronchial device, with proximalanchors carried on the central support structure, in accordance with analternative embodiment of the invention;

FIG. 12 is a perspective view of an intra-bronchial device, with distalfriction anchors carried on the central support structure, in accordancewith an alternative embodiment of the invention;

FIG. 13 is a side view of an intra-bronchial device, with distalfriction anchors carried on the central support structure, in accordancewith an alternative embodiment of the invention;

FIG. 14 is an end view of an intra-bronchial device, with distalfriction anchors carried on the central support structure, in accordancewith an alternative embodiment of the invention;

FIG. 15 is a perspective view of an intra-bronchial device similar tothat of FIGS. 12-14 anchored in an air passageway;

FIG. 16 is a perspective view illustrating an alternative embodiment ofa removable intra-bronchial device with proximal anchors carried on aperipheral portion of a plurality of support structure members in accordwith the present invention;

FIG. 17 is a side view of the device of FIG. 16;

FIG. 18 is a perspective view illustrating an alternative embodiment ofa removable intra-bronchial device with both distal and proximal anchorscarried on corresponding peripheral portions of the central supportstructure in accord with the present invention; and

FIG. 19 is a side view of the device of FIG. 18.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following detailed description of exemplary embodiments of theinvention, reference is made to the accompanying drawings that form apart hereof. The detailed description and the drawings illustrate howspecific exemplary embodiments by which the invention may be practiced.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention. It is understood thatother embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the present invention. Thefollowing detailed description is therefore not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

Throughout the specification and claims, the following terms take themeanings explicitly associated herein unless the context clearlydictates otherwise. The meaning of “a”, “an”, and “the” include pluralreferences. The meaning of “in” includes “in” and “on.” Referring to thedrawings, like numbers indicate like parts throughout the views.Additionally, a reference to the singular includes a reference to theplural unless otherwise stated or inconsistent with the disclosureherein.

Additionally, throughout the specification, claims, and drawings, theterm “proximal” means nearest the trachea, and “distal” means nearestthe bronchioles.

Briefly stated, an aspect of the invention provides an anchoredintra-bronchial device for placement in an air passageway of a patient.The intra-bronchial device obstructs the air passageway, reducing theventilation to a portion of the lung and/or collapsing the lung portionassociated with the air passageway. A further aspect of the inventionprovides removability of the intra-bronchial device, either by releasingthe anchors for removal of the entire device or by separating theobstructing member and removing it.

FIG. 1 is a sectional view of a healthy respiratory system. Therespiratory system 20 resides within the thorax 22 that occupies a spacedefined by the chest wall 24 and the diaphragm 26.

The respiratory system 20 includes the trachea 28, the left mainstembronchus 30, the right mainstem bronchus 32, the bronchial branches 34,36, 38, 40, and 42 and sub-branches 44, 46, 48, and 50. The respiratorysystem 20 further includes left lung lobes 52 and 54 and right lunglobes 56, 58, and 60. Each bronchial branch and sub-branch communicateswith a respective different portion of a lung lobe, either the entirelung lobe or a portion thereof. As used herein, the term “airpassageway” is meant to denote either a bronchi or bronchiole, andtypically means a bronchial branch or sub-branch which communicates witha corresponding individual lung lobe or lung lobe portion to provideinhaled air thereto or conduct exhaled air therefrom.

Characteristic of a healthy respiratory system is the arched or inwardlyarcuate diaphragm 26. As the individual inhales, the diaphragm 26straightens to increase the volume of the thorax 22. This causes anegative pressure within the thorax. The negative pressure within thethorax in turn causes the lung lobes to fill with air. When theindividual exhales, the diaphragm returns to its original archedcondition to decrease the volume of the thorax. The decreased volume ofthe thorax causes a positive pressure within the thorax which in turncauses exhalation of the lung lobes.

In contrast to the healthy respiratory system of FIG. 1, FIG. 2illustrates a respiratory system suffering from COPD. Here it may beseen that the lung lobes 52, 54, 56, 58, and 60 are enlarged and thatthe diaphragm 26 is not arched but substantially straight. Hence, thisindividual is incapable of breathing normally by moving diaphragm 26.Instead, in order to create the negative pressure in thorax 22 requiredfor breathing, this individual must move the chest wall outwardly toincrease the volume of the thorax. This results in inefficient breathingcausing these individuals to breathe rapidly with shallow breaths.

It has been found that the apex portions 62 and 66 of the upper lunglobes 52 and 56, respectively, are most affected by COPD. Hence,bronchial sub-branch obstructing devices are generally employed fortreating the apex 66 of the right, upper lung lobe 56. However, as willbe appreciated by those skilled in the art, the present invention may beapplied to any lung portion without departing from the presentinvention. As will be further appreciated by those skilled the in art,the present invention may be used with any type of obstructing member toprovide an anchored obstructing device, which may be removed. Theinventions disclosed and claimed in U.S. Pat. Nos. 6,258,100 and6,293,951, both of which are incorporated herein by reference, providean improved therapy for treating COPD by obstructing an air passagewayusing an intra-bronchial valve or plug. The present invention may beused with the apparatus, system, and methods of these patents as will bebriefly described in conjunction with the disclosure of the preferredembodiments of the present invention.

The insertion of an obstructing member treats COPD by deriving thebenefits of lung volume reduction surgery without the need of performingthe surgery. The treatment contemplates permanent collapse of a lungportion. This leaves extra volume within the thorax for the diaphragm toassume its arched state for acting upon the remaining healthier lungtissue. As previously mentioned, this should result in improvedpulmonary function due to enhanced elastic recoil, correction ofventilation/perfusion mismatch, improved efficiency of respiratorymusculature, and improved right ventricle filling. The present inventionsupports the use of intra-bronchial obstructions to treat COPD byanchoring the obstruction device in the air passageway. The presentinvention further supports the use of intra-bronchial obstructions byproviding for their removal if necessary. Use of anchors can allow theobstructing member to be relatively loosely fitted against the airpassageway wall, which may preserve mucociliary transport of mucus anddebris out of the collapsed lung portion and allow distal mucus to becoughed.

FIG. 2 also illustrates a step in COPD treatment using an obstructingmember. Treatment is initiated by feeding a conduit or catheter 70 downthe trachea 28, into the right mainstem bronchus 32, into the bronchialbranch 42 and into and terminating within the sub-branch 50. Thesub-branch 50 is the air passageway that communicates with the lungportion 66 to be treated, and is also referred to herein as airpassageway 50. The catheter 70 is preferably formed of flexible materialsuch as polyethylene. Also, the catheter 70 is preferably preformed witha bend 72 to assist the feeding of the catheter from the right mainstembronchus 32 into the bronchial branch 42.

FIG. 3 illustrates a further step in a method for placing an obstructingmember 90 in a bronchial sub-branch using a catheter. The inventiondisclosed herein is not limited to use with the particular methodillustrated herein. Catheter 70 includes an optional inflatable sealingmember 74 for use with a vacuum to collapse lung portion 66 prior toinsertion of obstructing member 90. The obstructing member 90 may beformed of resilient or collapsible material to enable the obstructingmember 90 to be fed through the conduit 70 in a collapsed state. Thestylet 92 is used to push the obstructing member 90 to the end 77 of thecatheter 70 for placing the obstructing member 90 within the airpassageway 50 adjacent to the lung portion 66 to be permanentlycollapsed. Optional sealing member 74 is withdrawn after obstructingmember 90 is inserted.

Another step in placing an obstructing member 90 may include sizing theair passageway location where the obstructing member 90 will bepositioned.

A function of the intra-bronchial device disclosed and claimed in thisspecification, including the detailed description and the claims, isdescribed in terms of collapsing a lung portion associated with an airpassageway. In some lungs, a portion of a lung may receive air fromcollateral air passageways. Obstructing one of the collateral airpassageways may reduce the volume of the lung portion associated withthe air passageway, but not completely collapse the lung portion, asthat term may be generally understood. As used herein, the meaning of“collapse” includes both a complete collapse of a lung portion, and apartial collapse resulting in a marked decrease in the volume of a lungportion.

Once deployed, the obstructing member precludes inhaled air fromentering the lung portion to be collapsed. In accordance with thepresent invention, it is preferable that the obstructing member takesthe form of a one-way valve. In addition to precluding inhaled air fromentering the lung portion, the member further allows air within the lungportion to be exhaled. This results in more rapid collapse of the lungportion. In addition, anchoring obstructing members that preclude bothinhaled and exhaled airflow are contemplated as within the scope of theinvention.

FIG. 4 illustrates the obstructing device in place within air passageway50. Obstructing member 90 has expanded upon placement in the airpassageway 50 to seal the air passageway 50. This causes the lungportion 66 to be maintained in a permanently collapsed state. Theobstructing member 90 may be any shape suitable for accomplishing itspurpose, and may be a solid material or a membrane.

More specifically, the obstructing member 90 has an outer dimension 91,and when expanded, enables a contact zone with the air passageway innerdimension 51. This seals the air passageway upon placement of theobstructing member 90 in the air passageway 50 for maintaining the lungportion 66 in the collapsed state.

Alternatively, the lung portion 66 may be collapsed using vacuum priorto placement of obstructing member 90, or sealing the air passageway 50with obstructing member 90 may collapse it. The air within the lungportion 66 will be absorbed by the body over time, reducing the volumeof and/or collapsing the lung portion 66. Alternatively, obstructingmember 90 may include the function of a one-way valve that allows air toescape from lung portion 66. Lung portion 66 will then collapse, and thevalve will prevent air from being inhaled.

FIG. 5 is a perspective view of an intra-bronchial device, with anchorslocated proximally on peripheral portions of the support members, as thedevice would appear when fully deployed in an air passageway inaccordance with the present invention. Intra-bronchial device 100includes a support structure 101, a central support structure 109;support members 102, 104, 106, and 108; anchors 112, 114, 116, and 118;anchor ends 122, 124, 126, and 128; and an obstructing member 110.

The support structure 101 of intra-bronchial device includes centralsupport structure 109, and support members 102, 104, 106, and 108. Thesupport members 102, 104, 106, and 108, carry anchors 112, 114, 116, and118; and anchor ends 122, 124, 126, and 128, respectively. Centralsupport structure 109 is a tubular member, preferably hypodermic needletubing. Support members 102, 104, 106, and 108, are coupled mechanicallyto central support structure 109, such as by crimping, or by othermethods such as adhesive or welding. Support members 102, 104, 106, and108 are generally similar to each other. The support members arepreferably formed of stainless steel, Nitinol, or other suitablematerial having a memory of its original shape, and resiliency to returnthe material to that shape.

Anchors 112, 114, 116, and 118 are extensions of support members 102,104, 106, and 108. The anchors are formed by bending the support membersto an angle that will result in a deployed anchor engaging the airpassageway wall by piercing it approximately perpendicularly. In thispreferred embodiment, the bend angle is approximately a right angle.Anchor ends 122, 124, 126, and 128 may be shaped to promote piercing theair passageway wall. In an alternative embodiment, the elements ofsupport structure 101 may be formed by laser cutting a single piece ofhypodermic needle tubing.

Obstructing member 110 is carried on the support structure 101, andincludes a flexible membrane open in the proximal direction and whichmay be formed of silicone or polyurethane, for example. The obstructingmember 110 is secured to the central support structure 109, and may beadditionally secured to the support members at its larger diameter 91.It may be secured by adhesive, or other manner known in the art.Obstructing member 110 may be loosely carried on support members 102,104, 106, and 108, such that it expands on inhalation to form a sealagainst a wall of the air passageway, and contracts on exhalation toallow air and mucociliary transport from the collapsed lung. Thisprovides a one-way valve function.

FIG. 6 is a partial section view of the device of FIG. 5 showingadditional detail of the support structure. The linear cross-sectionview of FIG. 6 exposes the arrangement of support members 106 and 108 intheir deployed configuration. The details of support members 102 and 104are omitted from FIG. 6 for clarity, but are the same as support members106 and 108. The distal end of obstructing member 110 is carried oncentral support structure 109. Support members 106 and 108 are shownemanating from central support structure 109, and arranged to looselysupport to obstructing member 110 at its larger diameter 91. This allowsobstructing member 110 to expand on inhalation and seal at the contactzone (element 129 of FIG. 7), and to partially contract on exhalation toallow exhalation of air and mucociliary transport. In an alternativeembodiment, support members 106 and 108 do not actively supportobstructing member 110, and the expansion and contraction of obstructingmember 110 is governed by its elasticity.

FIG. 7 is a perspective view of the intra-bronchial device of FIG. 5anchored in an air passageway. Intra-bronchial device 100 is illustratedwith anchors 112 and 116 piercing into the air passageway wall 130 ofair passageway 50. This anchors the intra-bronchial device 100 in place.

Intra-bronchial device 100 is collapsible for insertion into an internallumen of a catheter. At least the support members 102, 104, 106, and108, and the obstructing member 110, may be collapsed. Intra-bronchialdevice 100 is inserted into the catheter lumen, which is typicallyalready placed in the air passageway 50 as generally illustrated in FIG.3. Using the stylet, intra-bronchial device 100 is advanced down thecatheter lumen into the air passageway 50 to where the device is to bedeployed. Once the point of deployment is reached, intra-bronchialdevice 100 is expelled from the catheter and assumes its deployed shapeas illustrated in FIG. 5. Upon deployment, obstructing member 110 formsa contact zone 129 with the wall 130 of the air passageway 50 to preventair from being inhaled into the lung portion to collapse the lungportion. Simultaneously upon deployment, the memory and resiliency ofthe support members 102, 104, 106, and 108 impart a force on the anchorends 122, 124, 126, and 128, and urge the anchors 112, 114, 116, and 118to engage air passageway wall 130 by piercing. The anchors pierce intoand become embedded in the wall 130 of the air passageway 50, preferablywithout projecting through the wall 130. Stops may be incorporated intothe anchors to limit piercing of the wall 130. For example, the bendbetween the support member and the anchor may form a stop.

The preclusion of air from being inhaled into the lung portion may beterminated by eliminating the obstructing effect of intra-bronchialdevice 100. The preclusion of air by the embodiment illustrated in FIGS.5-7 may be eliminated by releasing anchors 112, 114, 116, and 118 fromthe air passageway wall 130. The anchors may be released by inserting acatheter into air passageway 50 in proximity to intra-bronchial device100. A retractor device, such as biopsy forceps, capable of gripping aportion of intra-bronchial device 100 is inserted in the catheter. Theforceps are used to engage a portion of the support structure 101 ofintra-bronchial device 100, such as a support member or an anchor, orthe obstructing member 110, and draw it toward the catheter. The drawingaction releases anchors 112, 114, 116, and 118 from air passageway wall130. The intra-bronchial device 110 is then drawn into the catheter withthe forceps, causing the support structure 101 and obstructing member110 to collapse. The collapsed device 100 now fully enters the catheterlumen for removal from the patient. Alternatively, the obstructingeffect may be eliminated by grabbing the obstructing member 110,releasing it from the support structure 101, and removing obstructingmember 110 from the patient.

FIG. 8 illustrates an intra-bronchial device, with anchors carrieddistally on the central support structure, fully deployed in an airpassageway in accordance with an alternative embodiment of theinvention. The anchors 112, 114, 116, and 118 of intra-bronchial device140 are carried on portions of support members 102, 104, 106, and 108distal of the central support structure 109. The support members aregathered together and carried by the central support structure 109.Other than the anchors 112, 114, 116, and 118 being formed and carriedon distal portions of support members 102, 104, 106, and 108,intra-bronchial device 140 is substantially similar in construction,operation, and removal as the intra-bronchial device 100 of FIG. 5.

When intra-bronchial device 140 is compressed for insertion into thecatheter lumen for placement in the air passageway, the anchors 112,114, 116, and 118 are collapsed into a first configuration. In the firstconfiguration, the anchor ends 122, 124, 126, and 128 are moved towardobstructing member 110, and anchors 112, 114, 116, and 118 therebyfolded toward obstructing member 110. In an alternative embodiment, theanchor ends 122, 124, 126, and 128 are moved away from obstructingmember 110, and anchors 112, 114, 116, and 118 thereby folded away fromobstructing member 110.

When intra-bronchial device 100 is deployed from the catheter lumen, thememory and resiliency of the anchors 112, 114, 116, and 118 impart aforce that moves the anchor ends 122, 124, 126, and 128 into a secondconfiguration to engage air passageway wall 130. This is the deployedconfiguration illustrated in FIG. 8. For removal, drawingintra-bronchial device 140 toward the catheter causes the anchor ends122, 124, 126, and 128 to move away from obstructing member 110 to athird configuration. Anchors 112, 114, 116, and 118 are thereby foldedaway from obstructing member 110 and are released from engagement withair passageway wall 130 for removal of the intra-bronchial device 140.In an alternative embodiment, the anchors 112, 114, 116, and 118 may beformed on additional support members carried by central supportstructure 109, instead of being formed from distal portions of supportmembers 102, 104, 106, and 108.

FIGS. 9-11 illustrate an intra-bronchial device, with proximal anchorscarried on the central support structure, in accordance with analternative embodiment of the invention. FIG. 9 is a perspective view,FIG. 10 is a side view, and FIG. 11 is an end view of the device.Intra-bronchial device 150 is generally similar in construction,operation, placement, and removal to the intra-bronchial device 100 ofFIG. 5. Its structure has six support members and three anchors, withanchor stops. Anchors 112, 114, and 116 include stops 152, 154, and 156respectively. Intra-bronchial device 150 also includes an anchor base161, an anchor base aperture 165, anchor base angle 163, and twoadditional support members 103 and 105.

Central support structure 109 extends both proximal and distal ofobstructing member 110, and carries anchor base 161 proximal ofobstructing member 110, carries anchors 112, 114, and 116, and includesanchor base aperture 165. The linear plane of anchors 112, 114, and 116intersect anchor base 161 at anchor base angle 163. Anchor base angle163 is selected to optimize anchor deployment force and anchor release.Stops 152, 154, and 156 include a flat area to limit the piercing of theair passageway wall by anchor ends 122, 124, and 126. In alternativeembodiments, the stops can be any configuration or shape known to thoseskilled in the art to limit the piercing.

In operation, when intra-bronchial device 150 is compressed forinsertion into the catheter lumen for placement in the air passageway,anchors 112, 114, and 116 are collapsed into a first configuration. Inthe first configuration, the anchor ends 122, 124, and 126 are movedtoward obstructing member 110, thereby decreasing anchor base angle 163and folding anchors 112, 114, and 116 toward obstructing member 110. Theanchor ends and the anchors may be moved by sliding a catheter or hollowmember over anchor base 161 and toward obstructing member 110. Whenintra-bronchial device 150 is deployed from the catheter lumen, thememory and resiliency of the anchors 112, 114, and 116, anchor angle163, and anchor base 161 impart a force that moves the anchor membersinto a second configuration, which is the deployed configuration, toengage air passageway wall 130. The second or deployed configuration isillustrated in FIGS. 9-11. Stops 152, 154, and 156 limit the piercing ofthe air passageway wall by anchor ends 122, 124, and 126.

For removal, a retractor device is deployed from a catheter to engageanchor base 161 and restrain intra-bronchial device 150. Anchor baseaperture 165 is arranged for being gripped by a retractor device. Theretractor device may be a biopsy forceps to engage anchor base 161, or ahooked device to engage anchor base aperture 165. The retractor deviceis then used to draw intra-bronchial device 150 proximal, releasing theanchors 112, 114, and 116 from the air passageway wall. This collapsesthe anchors into to the first configuration for removal.

In an alternative step to collapse the anchors, after anchor base 161 oraperture 165 is engaged, a catheter may then moved distally over anchorbase 161, and in contact with anchors 112, 114, and 116. The catheter isfurther moved against anchors 112, 114, and 116, while intra-bronchialdevice 150 is restrained at anchor base 161. This releases the anchors112, 114, and 116 from the air passageway wall. This collapses theanchors into to the first configuration for removal.

Continuing with the removal steps, intra-bronchial device 150 is thenfurther drawn into the catheter by pulling on the retractor device usedto engage anchor base 161. This collapses support structure 101 andobstructing member 110 so that they may be fully drawn into thecatheter. Once drawn into the catheter, intra-bronchial device 160 maybe removed from the air passageway and the patient.

FIGS. 12-14 illustrate an intra-bronchial device, with distal frictionanchors carried on the central support structure, in accordance with analternative embodiment of the invention. FIG. 12 is a perspective view,FIG. 13 is a side view, and FIG. 14 is an end view. Intra-bronchialdevice 160 is generally similar in construction, placement, andoperation to the intra-bronchial device 150 of FIGS. 9-11.Intra-bronchial device 160 is removed in the manner described inconjunction with FIG. 7. However, Intra-bronchial device 160 differsfrom intra-bronchial device 150 in that the structure includes fourdistal anchors with anchor ends 122, 124, 126, and 128 shaped into padsthat deform and frictionally engage the air passageway wall to morepositively anchor intra-bronchial device 160 without piercing. Thestructure also includes an obstructing member support base 170.

Central support structure 109 extends distal of obstructing member 110,and carries anchor base 161 distal of obstructing member 110. Anchorbase 161 carries anchors 112, 114, 116, and 118. The linear plane ofanchors 112, 114, 116, and 118 intersects anchor base 161 at anchorangle 163. Anchor angle 163 is selected to optimize anchor deploymentforce and anchor release. The anchors 112, 114, 116, and 118, and anchorbase 161 may be constructed by laser cutting a single piece ofhypodermic tubing lengthwise to form the anchors 112, 114, 116, and 118,and then bending the anchors to form anchor angle 163. Anchor base 161is secured to central support structure 109. Support members 102, 103,104, 105, 106, and 108, and the obstructing member support member base170 may be constructed in a like manner. Obstructing member 110 issecured to the obstructing member support base 170, and alternatively tosupport members 102, 103, 104, 105, 106, and 108. The assembly ofobstructing member 110 and support base 170 is secured to centralsupport structure 109. Central support structure 109 may extend proximalof support member base 170 to provide a surface for gripping theintra-bronchial device 160 for removal, and may include an aperture tobe engaged by a hooked device.

FIG. 15 is a perspective view of an intra-bronchial device similar tothat of FIGS. 12-14 anchored in an air passageway. It illustratespad-shaped anchor ends 122-128 of intra-bronchial device 180 deformingand frictionally engaging air passageway wall 130.

FIGS. 16 and 17 illustrate a removable intra-bronchial device withproximal anchors carried on a peripheral portion of a plurality ofsupport structure members in accord with the present invention. FIG. 16is a perspective view, as the device would appear when fully deployed inan air passageway. FIG. 17 is a side view of FIG. 16. In a preferredembodiment, the support structure 101 of intra-bronchial device 190includes six support members, with two opposing pairs of support memberscarrying anchors and each member of a pair being joined together by aretracting member. Intra-bronchial device 190 includes a supportstructure 101 having a central support structure 109 and support members102, 103, 104, 105, 106, and 108; four anchors 113, 114, 116, and 118having anchor ends 123, 124, 126, and 128 respectively; two “U” shapedretracting members 192 and 194 having an apex 193 and 195 respectively;and obstructing member 110.

Intra-bronchial device 190 is generally similar in construction,operation, placement, and removal to the intra-bronchial device 150 ofFIG. 9. Support structure 101 is a tubular member, preferably hypodermicneedle tubing, or stainless steel, Nitinol, or other suitable materialhaving a memory of its original shape and resiliency to return thematerial to that shape. Support members 102, 103, 104, 105, 106, and108, and central support structure 109 may be formed by laser cutting asingle piece of hypodermic needle tubing lengthwise, and bending thesupport members to a required shape. Support members 102, 103, 104, 105,106, and 108 are generally similar to each other. Anchors 113, 114, 116,and 118 are disposed on support members 103, 104, 106, and 108,respectively, in any manner available in the art. Anchors 113-118 aredisposed on support members 103, 104, 106, and 108 to be locatedproximally of obstructing member 110, and to engage an air passagewaywall when intra-bronchial device 190 is deployed.

“U” shaped retracting member 192 is coupled to support members 103 and104, and “U” shaped retracting member 194 is coupled to support members106 and 108. “U” shaped retracting members 192 and 194 may beconstructed of any material suitable for use within a patient, and mayor may not be resilient as required by the particular embodiment. Whenintra-bronchial device 190 is fully deployed in an air passageway, the“U” shaped retracting members 192 and 194 are arranged opposite eachother, and they partially overlap, with the apex of one lying within aspace bounded by the “U” shape of the other member. In the deployedconfiguration, increasing the distance between apex 193 and apex 195moves support member pairs 103-104 and 106-108 centrally.

In operation, when intra-bronchial device 190 is compressed forinsertion into a catheter lumen and placement in an air passageway,support members 102, 103, 104, 105, 106, and 108 are collapsed centrallyinto a first configuration. This causes the anchor ends 123, 124, 126and 128 to move centrally.

When intra-bronchial device 190 is deployed from the catheter lumen, thememory and resiliency of the support member pairs 103,104 and 106,108impart a force that moves the anchors 113 and 114, and 116 and 118, andtheir anchor ends 123 and 124, and 126 and 128 into a secondconfiguration, which is the deployed configuration to engage airpassageway wall. In addition, deployment of intra-bronchial device 190may include a step of forcibly decreasing the distance between apexes193 and 195 to forcibly move the anchors 113 and 114, and 116 and 118into engagement with the wall of the air passageway. While the anchors113 and 114, and 116 and 118 of this embodiment do not include stops,the expansive or peripheral movement of the anchors will be limited bythe interior surface of obstructing member 110. This may limit thepiercing of the air passageway wall by anchors 113 and 114, and 116 and118.

In an alternative embodiment, support member pairs 103,104 and 106,108may be compressed for insertion into a catheter lumen by a device thatincreases the distance between apex 193 and apex 195. Such a devicecould be a tool with spreading jaws, or a tapered member insertedbetween the apexes. The device could be left in engagement afterinsertion into the catheter, and then withdrawn to allow support memberpairs 103-104 and 106-108 to move apart and engage their anchors intothe wall of the air passageway.

For removal, a retractor device is deployed from a catheter lumen toengage apex 193 and 195, and restrain intra-bronchial device 190. Theretractor device may be any device that fits into the space defined byapexes 193 and 195 when the intra-bronchial device 190 is in its fullydeployed configuration. The retractor device is used to increase thedistance between apexes 193 and 195 until anchors 113, 114, 116, and118, and anchor ends 123, 124, 126, and 128 are released from the airpassageway wall. This collapses the anchors into to the firstconfiguration for removal. Intra-bronchial device 190 is then furthercollapsed, and drawn into the catheter by pulling on the retractordevice. This additionally collapses support structure 101 andobstructing member 110 into the first position so that they may be fullydrawn into the catheter. Once drawn into the catheter, intra-bronchialdevice 190 may be removed from the air passageway and the patient.

FIG. 18 is a perspective view illustrating an alternative embodiment ofa removable intra-bronchial device 200 with both distal and proximalanchors carried on corresponding peripheral portions of central supportstructure 109 in accord with the present invention. FIG. 19 is a sideview of the device 200 of FIG. 18. Intra-bronchial device 200 isgenerally similar in construction, placement, and operation tointra-bronchial device 150 of FIGS. 9-11. Intra-bronchial device 200 isremoved in the manner described in conjunction with FIG. 7.Intra-bronchial device 200 differs from intra-bronchial device 150 inthat the central support structure 109 carries distal anchors inaddition to the proximal anchors of device 150. Intra-bronchial device200 includes distal anchors 212, 213, 214, 216, and 218; anchor ends222, 223, 224, 226, and 228; and stops 252, 253, 254, 256, and 258.Intra-bronchial device 200 also include two more proximal anchors thandevice 150, which are proximal anchors 113 and 118; anchor ends 123 and128, and stops 153 and 158.

The central support structure 109 of support structure 101 extends bothdistally and proximally of obstructing member 110, and carries both theproximal anchors 112, 113, 114, 116, and 118 and distal anchors 212,213, 214, 216, and 218. The support structure 101 also includes supportmembers 102, 103, 104, 106, and 108. Because of the perspective of FIGS.18 and 19, several of the anchor members and several of the supportmembers are not visible. Intra-bronchial device 200 is expected toprovide additional anchoring force compared to the other embodimentsdisclosed herein.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments, other embodiments arepossible. Therefore, the spirit or scope of the appended claims shouldnot be limited to the description of the embodiments contained herein.It is intended that the invention resides in the claims hereinafterappended.

1. An intra-bronchial device for placement in an air passageway of a patient, the device comprising: a support structure comprising a plurality of support members extending from an attachment portion and terminating at free ends; a flexible and air-impermeable membrane carried by the support structure; and at least one anchor carried by the support structure that is configured to anchor the intra-bronchial device within the air passageway when the anchor is deployed; wherein the device is configured to permit air to flow in a first direction while preventing air flow past the device in a second direction that is opposite to the first direction.
 2. The device of claim 1, wherein the member obstructs air from being inhaled through the air passageway into a lung portion associated with the air passageway.
 3. The device of claim 1, wherein at least one anchor is configured to be released from the air passageway for removal of the intra-bronchial device.
 4. The device of claim 1, wherein at least one anchor is configured to be released from the air passageway when the support structure is moved proximally.
 5. The device of claim 1, wherein the support structure is configured to urge at least one anchor to engage the air passageway wall.
 6. The device of claim 1, wherein the support structure includes a central portion arranged for engaging a removal device.
 7. The device of claim 1, wherein the support structure is arranged such that drawing a central portion of the support structure proximally releases the at least one anchor without substantially skewing the intra-bronchial device in the air passageway.
 8. The device of claim 1, wherein the device is configured to permit air to flow in the first direction only along a path between the air-impermeable member and an air passageway wall.
 9. The device of claim 1, wherein the support members are configured to be radially collapsed and to return to an expanded shape upon release of a radial restraint.
 10. The device of claim 1, further comprising at least one anchor member attached to the frame and configured to retain the device against migration in an airway.
 11. The device of claim 1, wherein the support members are made of a material with a substantially rectangular cross-section.
 12. The device of claim 1, wherein the free ends of the support members are bent radially inwards.
 13. An intra-bronchial device comprising: a support structure comprising a plurality of support members extending in a curvilinear manner from an attachment; a flexible membrane carried by the support structure to form a substantially umbrella-shaped structure configured to be implanted in an air passageway to prevent air from flowing in a first direction past the device, while allowing fluid to travel past the obstructing member in an opposite direction.
 14. The device of claim 13, wherein the at least one anchor comprises an elongate member extending radially and axially from a portion of the support structure.
 15. The device of claim 13, wherein the membrane assumes a substantially parabolic shape in an expanded position.
 16. The device of claim 13, wherein the support members comprise tips at their free ends that are angled radially inwards.
 17. The device of claim 13, wherein the support members are configured to be radially collapsed and to return to an expanded shape upon release of a radial restraint. 